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ALEXANDRIA, Va. –The American Society of Clinical Oncology, Inc. (ASCO) and Foundation Medicine today announced entry into an agreement to create efficiencies for research sites participating in ASCO’s TAPUR™ Study in identifying potential participants for the study. ASCO is announcing that reports from Foundation Medicine’s comprehensive genomic profiling (CGP) assays, FoundationOne,® FoundationOne® Heme, and FoundationACT® will receive the new “optimized for TAPUR reporting” designation available to entities that demonstrate reporting of nearly 75% of TAPUR-specific genes in a format that meets criteria established for the TAPUR Study. The TAPUR Study is a first-of its-kind clinical trial designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the Food and Drug Administration.
As part of this pilot program, Foundation Medicine will use its SmartTrials™ technology to create reports for TAPUR sites that identify patients who may qualify to participate in the TAPUR Study. SmartTrials is a molecularly-matched, location-specific, clinical trials database that informs physicians about clinical trials to accelerate patient enrollment. Early use of the SmartTrials report by one TAPUR site was associated with a significant increase in patient accrual with the site reporting identification of more than 60 patients whose genomic profiles matched TAPUR drug targets within a few months of implementing the SmartTrials technology. As part of this arrangement, Foundation Medicine will be launching its SmartTrials reporting to an initial pilot set of the TAPUR Study’s participating clinical sites.
“We are excited to designate Foundation Medicine’s CGP assays as providing reports that are optimized for TAPUR participation and work with Foundation Medicine to allow TAPUR Sites to incorporate SmartTrials reporting to streamline identification of patients who may qualify for the TAPUR study,” said ASCO Chief Medical Officer and TAPUR Study Principal Investigator, Richard L. Schilsky, MD, FACP, FASCO, FSCT. “It is our hope that Foundation Medicine’s unique expertise in genomics will enable many more patients to access investigational therapies through the TAPUR Study clinical trial.”
“The TAPUR Study’s innovative, biomarker-driven design will expand access for patients to innovative new targeted therapies, while enhancing the collective understanding of the genomic basis of cancer biology,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “Applying the SmartTrials reporting to the TAPUR Study can facilitate rapid and accurate patient identification, accelerating patient enrollment.”
Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube.
About the TAPUR™ Study
The TAPUR Study is a non-randomized clinical trial that aims to describe the performance (both safety and efficacy) of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. The TAPUR Study provides approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies, catalogues the choice of genomic profiling test by clinical oncologists and aims to learn about the utility of registry data to develop hypotheses for additional clinical trials.
About Foundation Medicine
Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. Foundation Medicine’s SmartTrials program helps clinical research sponsors design, plan and implement clinical trials using Foundation Medicine’s oncology knowledge base and physician network. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).
Foundation Medicine® and FoundationOne® are registered trademarks and SmartTrialsTM is a trademark of Foundation Medicine, Inc.
ASCO®, American Society of Clinical Oncology® and TAPUR™ are trademarks of American Society of Clinical Oncology, Inc.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the value and performance capabilities of Foundation Medicine’s comprehensive genomic profiling assays; the ability of CGP and the SmartTrials services to help accelerate clinical trial enrollment; and the ability of a clinical trial, including the clinical trial design, to expand access to therapies or improve cancer care. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risk that Foundation Medicine's CGP and services will not be able to identify genomic alterations in the same manner as prior clinical data or prior experience; clinical trial enrollment does not increase in the expected manner; and the risks described under the caption "Risk Factors" in Foundation Medicine's Annual Report on Form 10-K for the year ended December 31, 2016, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.